Clascoterone

Suzhou, 12 August, 2025-Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), announced that the Phase II Clinical Trial of its in-house developed androgen receptor (AR) proteolysis targeting chimera (PROTAC) compound GT20029 for the treatment of acne has read out the topline results. Results indicated that the Phase II Clinical Trial has successfully met the primary study endpoint with statistically significant and clinically meaningful outcomes, demonstrating excellent efficacy, safety and pharmacokinetics. The recommended dosage for the phase III clinical trial was determined to be 0.5%. Detailed topline data are expected to be released in academic journals or academic conferences in the future. The Phase II Clinical Trial is a multi-center, randomized, double-blind, placebo-controlled study, which is designed to evaluate the efficacy, safety and pharmacokinetics of GT20029 for the treatment of acne through the adoption of GT20029 0.5% once-a-day (QD) and 1.0% QD as the drug-related dosage. The Phase II Clinical Trial involved a total of 10 clinical research  centers in China, and Professor Xiang Leihong (项蕾红) from Fudan University Huashan Hospital (复旦大学附属华山医院) is the lead principal investigator. The analysis results  demonstrated that:  Regarding efficacy, compared to the placebo group, in the total lesion counts (excluding nodules) category, the p value of 0.5% QD Group and 1.0% QD Group is 0.01 and 0.05, respectively. In the percent analysis of change in non-inflammatory lesion count from baseline, as compared to placebo, the p value of 0.5% QD Group and 1.0% QD Group is 0.14 and 0.09, respectively. In the percent analysis of change in inflammatory lesion count from baseline, as compared to placebo, both p value of 0.5% QD Group and 1.0% QD Group are lower than 0.01. As compared to placebo group, in the success rate (according to the Investigator’s Global Assessment (IGA) Scale, a decrease in IGA score to 0-1 and a decrease of ≥ 2 levels is defined as success), the p value of 0.5% QD Group and 1.0% QD Group is 0.03 and 0.15, respectively. In terms of safety, GT20029 gel exhibited satisfactory safety and tolerability in the clinical trial, with a low incidence of overall adverse events. The incidence of drug-related adverse events were comparable between 0.5% QD Group and 1.0% QD Group, which both are lower than that in the placebo group, with mild severity. GT20029, as one of our core products, is developed in-house by the Company based on its own PROTAC platform and has the potential to become a new generation of treatment for androgenetic alopecia and acne vulgaris. It, as always, has remained in a leading position since its development and is the world’s first topical PROTAC compound that has completed phase II clinical trial. We are formulating future clinical strategies for GT20029 for the treatment of  acne, including initiating a phase III clinical trial in China for the treatment of acne, to further expand our first-mover advantage in topical PROTAC. Winlevi® (clascoterone 1%, cream) is the first acne drug with a new mechanism of action (MOA) approved by the U.S. Food and Drug Administration (FDA) in the past 40 years to treat acne vulgaris in patients of 12 years of age and older. According to Cosmo Pharmaceuticals N.V.’s public disclosure, Winlevi® has become the most prescribed branded topical acne drug in the U.S. market, with over 1.3 million prescriptions written by more than 17,900 prescribers since its launch. The approval of an acne drug targeting AR demonstrates that the MOA of treating acne by blocking or degrading the AR signaling pathway has been validated. GT20029 is expected to provide dermatologists and patients with an innovative, safe and effective new treatment option. About Kintor Pharmaceutical Limited Founded in 2009, Kintor Pharmaceutical Limited focuses on developing and commercializing potential "first-in-class" and "best-in-class" innovative drugs and functional cosmetics, aiming to be a leading enterprise in such areas, and establish a “troika” business model formed by R&D business of innovative topical drugs, B2B business of functional cosmetic raw materials and B2C business of functional cosmetic products. After several years' development, the Company has developed diverse product pipeline built on dermatology and oncology related diseases. The products cover diseases with high incidence rate globally and extend to functional cosmetics, which can meet the needs of clinical dermatology and cosmetics consumers worldwide. Kintor Pharma's layout includes innovative small molecule and biologic drugs, consisting of five productsunder clinical development and several preclinical research programs. Kintor Pharma has been granted more than 100 patents worldwide. On 22 May 2020, Kintor Pharma was officially listed on the Hong Kong Stock Exchange with the stock code 9939.HK. For more information, please visit www.kintor.com.cn.

The idea behind denifanstat is to decrease cytokine secretion in order to inhibit the production of facial sebum.\n Ascletis Pharma’s acne pill has scored a phase 3 win, leading the Chinese biotech to claim the Sagimet Biosciences-sourced drug can hold its own against FDA-approved products like Seysara and doxycycline.The Chinese study saw 480 patients with moderate to severe acne vulgaris receive either a once-daily 50-mg dose of the oral fatty acid synthase inhibitor denifanstat or placebo for 12 weeks. The trial hit all three of its primary endpoints, including a 18.6% placebo-adjusted increase in the proportion of patients who achieved success as defined by a skin clearance score.Specifically, 33.2% of patients receiving denifanstat were assessed as having clear or almost clear skin at Week 12, compared to 14.6% of patients on placebo.The average reduction in skin lesions in the denifanstat group was 57.4% compared to 35.4% for those on placebo. When it came to a reduction in inflammatory lesions, the drop was 63.5% and 43.2%, respectively.While the trial was not designed to make head-to-head comparisons with existing acne products, Ascletis laid out its data alongside past results for potential competitors. This included comparing denifanstat’s 18.6% placebo-adjusted treatment success to 9.4% for Almirall’s Seysara, doxycycline’s 6.7% and 11.6% for clascoterone cream.Ascletis pointed to these comparisons as evidence that denifanstat “has the potential to be a first-in-class, once-daily, oral acne therapeutic, potentially offering both exceptional efficacy and patient compliance with a favorable safety and tolerability profile.”As an oral option, Ascletis also hopes denifanstat could ensure better adherence from patients than the current crop of topical treatments.When it came to safety, the denifanstat and placebo cohorts had a similar profile, the biotech said. The only treatment-related adverse events that affected slightly more than 5% of patients in the denifanstat arm were dry skin and dry eye. The idea behind denifanstat is to decrease cytokine secretion in order to inhibit the production of facial sebum, which is an underlying cause of acne. It means that, unlike some other acne treatments, denifanstat doesn’t have the potential to lead to antibiotic resistance or the off-target effects that can be seen with tetracycline antibiotics, Ascletis said.“We are extremely pleased with the topline results of our phase 3 trial,” Ascletis CEO Jinzi Jason Wu, Ph.D., said in the release.“Denifanstat tablets demonstrated impressive efficacy beyond treatment success, showing significant reductions in total lesion count, inflammatory lesion count, and non-inflammatory lesion count,” Wu added. “We are excited to be submitting this innovative treatment with the China National Medical Products Administration soon.”Ascletis licensed the China rights to denifanstat from Sagimet back in 2019 with the initial aim of exploring the drug in a liver disease called metabolic dysfunction-associated steatohepatitis. Work on this indication appears to have stalled, with Ascletis stating in March that the company will “make further assessment and seek opportunities to maximize the value of this program.”Antiviral, cancer and liver disease drug candidates were central to Ascletis’ strategy when the company went public in 2018. However, the biotech suffered setbacks in the clinic in its original core areas, including axing hepatitis B and liver disease programs. More recently, Ascletis has unveiled and quickly advanced a weight loss pipeline that features oral and subcutaneous formulations of a GLP-1 receptor agonist, leading the biotech to formalize its pivot to metabolic disease earlier this year.